NCT06739525

Brief Summary

This study investigates the effects of blue light-blocking glasses compared to standard lenses on contrast sensitivity and visual fatigue in myopic and non-myopic adults. With the growing use of digital screens, blue light exposure has raised concerns due to potential eye strain, sleep disruption, and visual fatigue.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2024

Geographic Reach
1 country

1 active site

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 28, 2024

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2024

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 13, 2024

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 18, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2025

Completed
Last Updated

December 18, 2024

Status Verified

December 1, 2024

Enrollment Period

5 months

First QC Date

December 13, 2024

Last Update Submit

December 13, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Contrast Sensitivity

    Measured using the Pelli-Robson chart to assess changes in visual acuity and sensitivity to contrast under different lens conditions.

    12 Months

  • Visual Fatigue

    The Visual Fatigue Questionnaire (VFQ) was assessed to evaluate subjective experiences of eye strain and fatigue during visual tasks. Computer Vision Syndrome: Evaluated with the Computer Vision Syndrome Questionnaire (CVS-Q) to quantify symptoms associated with prolonged screen use, including dryness, discomfort, and eye strain."

    12 months

Study Arms (2)

interventional group

EXPERIMENTAL
Combination Product: Blue Light-Blocking Glasses (Intervention Group)

Control Group

ACTIVE COMPARATOR
Diagnostic Test: Standard Lenses (Control Group)

Interventions

Participants in this arm wore blue light-blocking glasses designed to filter out a portion of short-wavelength blue light. These lenses were intended to reduce eye strain and protect against blue light exposure, especially during prolonged screen time. Participants used blue light-blocking glasses consistently throughout the study period to assess their effect on contrast sensitivity and visual fatigue.

interventional group

Participants in this arm wore standard lenses without any blue light-blocking properties. These lenses allow the full spectrum of visible light to pass through and serve as a baseline control to measure against the blue light-blocking glasses. Participants used these lenses under the same conditions to assess contrast sensitivity and visual fatigue without blue light filtration.

Control Group

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 18-50 years.
  • Both myopic (with any degree of myopia) and non-myopic adults.
  • Participants who use computer screens for at least four hours per day.
  • Individuals currently using corrective lenses or willing to wear study-provided glasses during the experiment.
  • Individuals willing to complete the study protocol, which includes attending follow-up examinations and filling out visual fatigue questionnaires.

You may not qualify if:

  • A history of any serious vision-related condition (such as glaucoma, cataracts, or retinal problems).
  • Individuals who have already undergone refractive surgery (e.g., LASIK) or other types of eye surgery.
  • Systemic conditions affecting vision include diabetes, neurological problems, and any other ailment that may impair visual ability.
  • Taking drugs that are known to impair vision or produce visual tiredness (for example, certain antihistamines and antidepressants).
  • Pregnant women's visual performance may be affected by hormonal changes.
  • People with uncorrected vision difficulties cannot use the prescription lenses during study time.
  • Participants who are allergic or sensitive to lens materials.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tehsil Headquarters (THQ)

Taunsa, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Myopia

Condition Hierarchy (Ancestors)

Refractive ErrorsEye Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

December 13, 2024

First Posted

December 18, 2024

Study Start

February 28, 2024

Primary Completion

August 1, 2024

Study Completion

January 31, 2025

Last Updated

December 18, 2024

Record last verified: 2024-12

Data Sharing

IPD Sharing
Will not share

Locations